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A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01186744
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : June 4, 2014
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: CP-690,550
Enrollment 666
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A) CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg CP-690,550 5 mg/Placebo/CP-690,550 5 mg CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg CP-690,550 10 mg / Placebo / CP-690,550 10 mg
Hide Arm/Group Description Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment) Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment) Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Period Title: Overall Study
Started 218 157 31 82 45 133
Completed 10 5 25 70 39 107
Not Completed 208 152 6 12 6 26
Reason Not Completed
Lack of Efficacy             156             99             0             2             2             5
Protocol Violation             1             2             0             1             1             2
Lost to Follow-up             15             16             2             1             1             4
Screen failure             1             1             0             1             0             0
Withdrawal by Subject             14             10             2             5             0             6
Study terminated by Sponsor             1             0             0             0             0             0
Not specified             9             10             1             2             1             5
Adverse Event             10             14             1             0             1             4
Death             1             0             0             0             0             0
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A) CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg CP-690,550 5 mg/Placebo/CP-690,550 5 mg CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg CP-690,550 10 mg / Placebo / CP-690,550 10 mg Total
Hide Arm/Group Description Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment) Total of all reporting groups
Overall Number of Baseline Participants 218 157 31 82 45 133 666
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants who were randomized at baseline and received at least one dose of the randomized investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period A.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 218 participants 157 participants 31 participants 82 participants 45 participants 133 participants 666 participants
42.8  (13.0) 45.6  (12.6) 44.3  (13.0) 45.2  (13.4) 48.5  (14.8) 46.1  (13.4) 44.9  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 218 participants 157 participants 31 participants 82 participants 45 participants 133 participants 666 participants
Female
65
  29.8%
50
  31.8%
11
  35.5%
27
  32.9%
11
  24.4%
44
  33.1%
208
  31.2%
Male
153
  70.2%
107
  68.2%
20
  64.5%
55
  67.1%
34
  75.6%
89
  66.9%
458
  68.8%
1.Primary Outcome
Title Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
Time Frame Weeks 4, 8 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
The Period B-Full Analysis Set (FAS-B) included all participants who were re-randomized at the end of Period A and received at least 1dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) or placebo at the beginning of Period B.
Arm/Group Title CP-690,550 5 mg (Period B) Placebo for CP-690,550 5 mg (Period B) CP-690,550 10 mg (Period B) Placebo for 10 mg CP-690,550
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
90.3
(72.9 to 96.8)
63.4
(52.0 to 72.8)
91.1
(78.0 to 96.6)
61.4
(52.5 to 69.1)
Week 8
70.3
(50.6 to 83.3)
36.2
(25.8 to 46.7)
86.6
(72.5 to 93.7)
39.6
(31.2 to 47.9)
Week 12
63.2
(43.4 to 77.7)
32.4
(22.4 to 42.7)
77.2
(61.7 to 87.0)
33.4
(25.4 to 41.5)
Week 16
56.2
(36.7 to 71.8)
23.3
(14.7 to 33.1)
62.3
(45.8 to 75.0)
26.1
(18.8 to 33.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg (Period B), Placebo for CP-690,550 5 mg (Period B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0008
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg (Period B), Placebo for 10 mg CP-690,550
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for CP-690,550 5 mg (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
80.6
(61.9 to 90.8)
57.3
(45.9 to 67.2)
80.0
(65.1 to 89.1)
52.3
(43.4 to 60.4)
Week 8
67.7
(48.4 to 81.2)
34.4
(24.2 to 44.8)
80.0
(65.1 to 89.1)
32.5
(24.6 to 40.6)
Week 12
60.6
(41.1 to 75.4)
26.7
(17.6 to 36.8)
66.3
(50.4 to 78.1)
23.8
(16.8 to 31.4)
Week 16
49.9
(31.0 to 66.2)
22.9
(14.4 to 32.6)
63.9
(48.0 to 76.1)
18.0
(11.9 to 25.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CP-690,550 5 mg BID (Period B), Placebo for CP-690,550 5 mg (Period B)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0027
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CP-690,550 10 mg BID (Period B), Placebo for 10 mg CP-690,550
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 2 38 3 59
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
50.00
(0.00 to 100.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Week 4
100.00
(100.00 to 100.00)
13.16
(2.41 to 23.91)
0.00
(0.00 to 0.00)
40.68
(28.14 to 53.21)
Week 8
100.00
(100.00 to 100.00)
31.58
(16.80 to 46.36)
0.00
(0.00 to 0.00)
49.15
(36.40 to 61.91)
Week 16
50.00
(0.00 to 100.00)
31.58
(16.80 to 46.36)
0.00
(0.00 to 0.00)
50.85
(38.09 to 63.60)
4.Primary Outcome
Title Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B)
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
The Period C-Full Analysis Set (FAS-C) included all FAS-B participants who were advanced to the re-treatment period (Period C) during the 16 weeks of Period B and had received at least one dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period C.
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 13 58 15 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
23.08
(0.17 to 45.98)
5.17
(0.0 to 10.87)
6.67
(0.0 to 19.29)
7.14
(2.04 to 12.24)
Week 4
23.08
(0.17 to 45.98)
25.86
(14.59 to 37.13)
33.33
(9.48 to 57.19)
51.02
(41.12 to 60.92)
Week 8
30.77
(5.68 to 55.86)
39.66
(27.07 to 52.24)
40.0
(15.21 to 64.79)
55.10
(45.25 to 64.95)
Week 16
30.77
(5.68 to 55.86)
41.38
(28.70 to 54.05)
53.33
(28.09 to 78.58)
48.98
(39.08 to 58.88)
5.Secondary Outcome
Title Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
Time Frame Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
The Period A-Full Analysis Set (FAS-A) included all participants who were randomized at baseline and received at least 1 dose of the randomized investigational drug (CP-690,550 5mg BID or 10 mg BID) during Period A.
Arm/Group Title CP-690,550 5 mg (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 330 333
Median (95% Confidence Interval)
Unit of Measure: weeks
24.3
(24.1 to 24.6)
8.7
(8.1 to 15.4)
6.Secondary Outcome
Title Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
Hide Description The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).
Time Frame Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A
Arm/Group Title CP-690,550 5 mg (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 329 333
Median (95% Confidence Interval)
Unit of Measure: weeks
24.1
(16.6 to 24.4)
8.1 [1] 
(NA to NA)
[1]
95% confidence interval cannot be estimated due to less than (<)50% of events occurring and/or censoring issue.
7.Secondary Outcome
Title Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A)
Hide Description PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A
Arm/Group Title CP-690,550 5 mg (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
12.69
(9.10 to 16.27)
21.19
(16.82 to 25.57)
Week 8
18.73
(14.53 to 22.93)
19.40
(15.17 to 23.64)
Week 16
18.13
(13.98 to 22.28)
13.13
(9.52 to 16.75)
Week 24
10.88
(7.52 to 14.23)
10.15
(6.92 to 13.38)
8.Secondary Outcome
Title Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Hide Description Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B
Arm/Group Title CP-690,550 5 mg (Period B) Placebo for 5 mg CP-690,550 (Period B) CP-690,550 10 mg (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
100.0
(100.0 to 100.0)
90.0
(81.0 to 94.9)
100.0
(100.0 to 100.0)
85.9
(78.6 to 90.9)
Week 8
96.7
(78.6 to 99.5)
72.0
(60.6 to 80.6)
97.7
(84.6 to 99.7)
68.4
(59.5 to 75.7)
Week 12
96.7
(78.6 to 99.5)
58.8
(47.0 to 68.8)
93.0
(79.9 to 97.7)
58.5
(49.4 to 66.6)
Week 16
92.3
(72.1 to 98.0)
32.8
(16.3 to 50.4)
93.0
(79.9 to 97.7)
42.9
(30.5 to 54.6)
9.Secondary Outcome
Title Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
Hide Description Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B
Arm/Group Title CP-690,550 5 mg (Period B) Placebo for 5 mg CP-690,550 (Period B) CP-690,550 10 mg (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
16.4 [2] 
(12.6 to NA)
NA [1] 
(NA to NA)
16.1 [2] 
(14.1 to NA)
[1]
Median and 95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
[2]
95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
10.Secondary Outcome
Title Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B)
Hide Description The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.
Time Frame Weeks 4 and 8 (Period B)
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Hide Analysis Population Description
FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 8 of Period B.
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 (Period B) CP-690,550 10 mg (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 44 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4 (n=30,82,43,128)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Week 8 (n=31,70,43,106)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Overall (n=31,82,44,132)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
11.Secondary Outcome
Title Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B)
Hide Description The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 16 of Period B.
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 (Period B) CP-690,550 10 mg (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 132
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 (n=30,82,43,128) 0.00 0.00 0.00 0.00
Week 8 (n=31,70,43,106) 0.00 0.00 0.00 0.00
Week 12 (n=30,53,43,87) 0.00 0.00 0.00 1.15
Week 16 (n=28,45,38,72) 0.00 0.00 0.00 0.00
Overall (n=31,82,45,132) 0.00 0.00 0.00 0.76
12.Secondary Outcome
Title Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Hide Description Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.
Time Frame Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
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Hide Analysis Population Description
FAS-B
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 132
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
100.00
(100.0 to 100.0)
90.0
(81.0 to 94.9)
100.0
(100.0 to 100.0)
85.9
(78.6 to 90.9)
Week 8
96.7
(78.6 to 99.5)
72.0
(60.6 to 80.6)
97.7
(84.6 to 99.7)
68.4
(59.5 to 75.7)
Week 12
96.7
(78.6 to 99.5)
58.8
(47.0 to 68.8)
93.0
(79.9 to 97.7)
58.4
(49.3 to 66.5)
Week 16
92.3
(72.1 to 98.0)
32.8
(16.3 to 50.4)
93.0
(79.9 to 97.7)
43.5
(31.0 to 55.3)
13.Secondary Outcome
Title Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
Hide Description [Not Specified]
Time Frame Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
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Hide Analysis Population Description
FAS-B
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 132
Median (95% Confidence Interval)
Unit of Measure: weeks
NA [1] 
(NA to NA)
16.4 [2] 
(12.6 to NA)
NA [1] 
(NA to NA)
16.1 [2] 
(14.1 to NA)
[1]
Median and 95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
[2]
95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
14.Secondary Outcome
Title Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Weeks 4, 8, and 16 (Period C)
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Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 7 52 7 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
14.3
(2.1 to 66.6)
7.7
(3.0 to 19.2)
14.3
(2.1 to 66.6)
37.0
(27.6 to 48.5)
Week 8
28.6
(8.0 to 74.2)
32.3
(21.2 to 47.3)
42.9
(16.3 to 82.8)
48.5
(38.2 to 60.0)
Week 16
64.3
(22.0 to 98.6)
100.0 [1] 
(NA to NA)
42.9
(16.3 to 82.8)
57.2
(46.2 to 68.8)
[1]
95% confidence interval could not be estimated due to censoring.
15.Secondary Outcome
Title Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 7 52 7 81
Median (95% Confidence Interval)
Unit of Measure: weeks
16.4 [1] 
(8.6 to NA)
16.4
(16.1 to 17.3)
NA [2] 
(NA to NA)
12.4 [1] 
(7.6 to NA)
[1]
95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
[2]
Median and 95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
16.Secondary Outcome
Title Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion.
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
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Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 7 52 7 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Baseline
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
0.00
(0.00 to 0.00)
Week 4
14.29
(0.00 to 40.21)
7.69
(0.45 to 14.93)
14.29
(0.00 to 40.21)
37.04
(26.52 to 47.55)
Week 8
28.57
(0.00 to 62.04)
28.85
(16.53 to 41.16)
42.86
(6.2 to 79.52)
41.98
(31.23 to 52.72)
Week 16
28.57
(0.00 to 62.04)
21.15
(10.05 to 32.25)
42.86
(6.20 to 79.52)
41.98
(31.23 to 52.72)
17.Secondary Outcome
Title Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B)
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 2 38 3 59
Median (95% Confidence Interval)
Unit of Measure: weeks
4.5
(4.3 to 4.7)
16.4
(16.1 to 17.3)
NA [1] 
(NA to NA)
8.1
(5.9 to 16.1)
[1]
Median and 95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
18.Secondary Outcome
Title Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C
Hide Description [Not Specified]
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
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Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 10 55 14 91
Median (95% Confidence Interval)
Unit of Measure: weeks
16.3
(16.1 to 16.4)
16.1
(8.4 to 16.6)
13.1 [1] 
(6.0 to NA)
8.1
(5.0 to 16.1)
[1]
95% confidence interval cannot be estimated due to <50% of events occurring and/or censoring issue.
19.Secondary Outcome
Title Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
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Hide Analysis Population Description
FAS-A
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
7.85
(4.96 to 10.75)
22.39
(17.92 to 26.85)
Week 8
23.87
(19.27 to 28.46)
50.45
(45.09 to 55.80)
Week 16
38.07
(32.84 to 43.30)
60.60
(55.36 to 65.83)
Week 24
38.97
(33.72 to 44.23)
59.40
(54.14 to 64.66)
20.Secondary Outcome
Title Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 87.10 63.41 86.67 59.40
Week 8 70.97 34.15 86.67 38.35
Week 12 67.74 30.49 77.78 33.83
Week 16 64.52 24.39 62.22 27.82
21.Secondary Outcome
Title Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)
Hide Description PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Time Frame Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 75 42 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
70.37
(53.15 to 87.59)
34.67
(23.90 to 45.44)
73.81
(60.51 to 87.11)
60.83
(52.10 to 69.57)
Week 8
62.96
(44.75 to 81.18)
48.00
(36.69 to 59.31)
66.67
(52.41 to 80.92)
68.33
(60.01 to 76.66)
Week 16
55.56
(36.81 to 74.30)
45.33
(34.07 to 56.60)
69.05
(55.07 to 83.03)
61.67
(52.97 to 70.37)
22.Secondary Outcome
Title Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
Hide Description PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
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FAS-A
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
14.20
(10.44 to 17.96)
37.91
(32.72 to 43.11)
Week 8
30.51
(25.55 to 35.47)
54.03
(48.69 to 59.37)
Week 16
37.16
(31.95 to 42.37)
58.81
(53.54 to 64.08)
Week 24
37.16
(31.95 to 42.37)
55.22
(49.90 to 60.55)
23.Secondary Outcome
Title Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)
Hide Description PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
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FAS-B
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 77.42 57.32 77.78 48.12
Week 8 74.19 32.93 82.22 33.08
Week 12 70.97 28.05 66.67 26.32
Week 16 58.06 28.05 62.22 21.05
24.Secondary Outcome
Title Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)
Hide Description PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion.
Time Frame Weeks 4, 8, and 16 (Period C)
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FAS-C
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 75 42 120
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
62.96
(44.75 to 81.18)
40.00
(28.91 to 51.09)
61.90
(47.22 to 76.59)
59.17
(50.37 to 67.96)
Week 8
62.96
(44.75 to 81.18)
49.33
(38.02 to 60.65)
54.76
(39.71 to 69.81)
63.33
(54.71 to 71.96)
Week 16
55.56
(36.81 to 74.30)
49.33
(38.02 to 60.65)
59.52
(44.68 to 74.37)
55.00
(46.10 to 63.90)
25.Secondary Outcome
Title Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)
Hide Description Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Time Frame Baseline and Weeks 4, 8, 16, and 24 (Period A)
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Hide Analysis Population Description
FAS-A; n equals the number of participants with an observation.
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Baseline (n=331,335) 27.5  (0.9) 27.2  (0.9)
Week 4 (n=326,331) 22.3  (0.9) 18.1  (0.8)
Week 8 (n=322,323) 17.2  (0.9) 12.1  (0.8)
Week 16 (n=311,306) 13.3  (0.8) 8.1  (0.7)
Week 24 (n=277,279) 12.0  (0.8) 6.4  (0.7)
26.Secondary Outcome
Title Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Hide Description Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Time Frame Baseline and Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals the number of participants with observations
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Baseline (n=31,82,45,133) 1.9  (0.4) 3.8  (0.8) 2.0  (0.3) 2.7  (0.4)
Week 4 (n=30,82,43,128) 1.9  (0.4) 6.1  (0.8) 1.8  (0.4) 6.8  (0.9)
Week 8 (n=30,70,43,104) 2.2  (0.4) 7.7  (1.2) 2.0  (0.4) 8.7  (1.2)
Week 12 (n=28,53,42,84) 2.0  (0.4) 7.2  (1.0) 2.3  (0.5) 6.2  (0.9)
Week 16 (n=28,45,38,70) 2.2  (0.5) 6.0  (0.9) 2.6  (0.7) 6.0  (0.8)
27.Secondary Outcome
Title Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Hide Description Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C; n equals the number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 75 42 120
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Baseline (n=27,75,42,120) 2.3  (0.5) 11.4  (1.3) 3.0  (0.8) 12.0  (1.2)
Week 4 (n=27,74,42,119) 2.1  (0.4) 10.6  (1.7) 3.1  (0.9) 7.2  (0.9)
Week 8 (n=26,72,41,118) 2.5  (0.5) 9.0  (1.6) 3.3  (1.0) 6.1  (0.8)
Week 16 (n=23,67,39,101) 2.9  (0.5) 7.1  (1.2) 3.7  (1.3) 4.5  (0.8)
28.Secondary Outcome
Title Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)
Hide Description Baseline defined as the last observation up to first dosing date in Period A.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 326 331
Mean (Standard Error)
Unit of Measure: percent change in psoriatic BSA
Week 4 (n=326,331) -5.3  (0.5) -9.0  (0.7)
Week 8 (n=322,323) -10.4  (0.7) -14.5  (0.8)
Week 16 (n=311,306) -14.4  (0.8) -18.5  (0.9)
Week 24 (n=277,279) -15.2  (0.9) -19.4  (0.9)
29.Secondary Outcome
Title Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
Hide Description Baseline defined as the last observation up to first dosing date in Period B.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals the number of participants with observations
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 30 82 43 128
Mean (Standard Error)
Unit of Measure: percent change in psoriatic BSA
Week 4 (n=30,82,43,128) 0.0  (0.4) 2.3  (0.9) -0.3  (0.3) 4.1  (0.6)
Week 8 (n=30,70,43,104) 0.3  (0.4) 4.1  (0.9) -0.1  (0.4) 6.3  (0.9)
Week 12 (n=28,53,42,84) 0.1  (0.5) 4.8  (1.0) 0.3  (0.6) 4.7  (0.7)
Week 16 (n=28,45,38,70) 0.3  (0.5) 3.7  (0.7) 0.5  (0.7) 4.5  (0.7)
30.Secondary Outcome
Title Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
Hide Description Baseline was defined as the last observation until first dosing date in Period C.
Time Frame Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 74 42 119
Mean (Standard Error)
Unit of Measure: percent change in psoriatic BSA
Week 4 (n=27,74,42,119) -0.2  (0.3) -1.0  (1.0) 0.1  (0.9) -4.9  (0.8)
Week 8 (n=26,72,41,118) 0.1  (0.5) -2.3  (1.0) 0.3  (0.9) -5.5  (0.8)
Week 16 (n=23,67,39,101) 0.5  (0.6) -4.0  (1.1) 0.6  (1.2) -6.8  (0.8)
31.Secondary Outcome
Title Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Hide Description Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Time Frame Baseline and Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Head/Neck, Baseline (n=331,335) 28.7  (1.25) 25.9  (1.17)
Head/Neck, Week 4 (n=326,331) 20.5  (1.20) 14.3  (1.04)
Head/Neck, Week 8 (n=322,323) 14.8  (1.06) 9.7  (0.96)
Head/Neck, Week 16 (n=311,306) 12.6  (1.05) 7.5  (0.88)
Head/Neck, Week 24 (n=277,279) 12.8  (1.17) 6.3  (0.89)
Upper limbs, Baseline (n=331,335) 26.5  (1.04) 26.2  (1.06)
Upper limbs, Week 4 (n=326,331) 21.8  (1.02) 17.3  (0.91)
Upper limbs, Week 8 (n=322,323) 17.0  (0.95) 11.7  (0.83)
Upper Limbs, Week 16 (n=311,306) 13.6  (0.92) 8.0  (0.70)
Upper limbs, Week 24 (n=277,279) 12.2  (0.98) 6.5  (0.65)
Trunk, Baseline (n=331,335) 26.0  (1.23) 25.9  (1.18)
Trunk, Week 4 (n=326,331) 20.8  (1.16) 17.2  (1.02)
Trunk, Week 8 (n=322,323) 16.5  (1.11) 11.4  (0.94)
Trunk, Week 16 (n=311,306) 13.5  (1.05) 8.5  (0.95)
Trunk, Week 24 (n=277,279) 12.5  (1.05) 6.9  (0.85)
Lower limbs, Baseline (n=331,335) 28.7  (1.14) 28.9  (1.12)
Lower limbs, Week 4 (n=326,331) 24.1  (1.13) 20.2  (0.99)
Lower limbs, Week 8 (n=322,323) 18.5  (1.05) 13.4  (0.93)
Lower limbs, Week 16 (n=311,306) 13.1  (0.95) 7.9  (0.79)
Lower limbs, Week 24 (n=277,279) 11.3  (0.90) 6.1  (0.71)
32.Secondary Outcome
Title Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Hide Description Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Time Frame Baseline and Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals the number of participants with observations
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Head/Neck, Baseline (n=31,82,45,133) 4.2  (1.53) 3.3  (0.79) 0.9  (0.34) 2.8  (0.70)
Head/Neck, Week 4 (n=30,82,43,128) 4.1  (1.44) 11.3  (1.99) 1.5  (0.44) 12.2  (1.59)
Head/Neck, Week 8 (n=30,70,43,104) 4.8  (1.80) 13.0  (2.34) 1.5  (0.46) 15.1  (1.97)
Head/Neck, Week 12 (n=28,53,42,84) 3.8  (1.00) 13.5  (2.96) 2.8  (0.72) 11.5  (2.03)
Head/Neck, Week 16 (n=28,45,38,70) 3.8  (1.19) 9.2  (2.11) 2.3  (0.80) 9.6  (1.76)
Upper limbs, Baseline (n=31,82,45,133) 2.1  (0.42) 5.1  (1.00) 3.1  (0.55) 3.1  (0.50)
Upper limbs, Week 4 (n=30,82,43,128) 2.4  (0.48) 7.5  (1.19) 3.0  (0.55) 7.6  (0.97)
Upper limbs, Week 8 (n=30,70,43,104) 2.8  (0.58) 8.9  (1.41) 3.6  (0.68) 8.9  (1.25)
Upper limbs, Week 12 (n=28,53,42,84) 3.1  (0.59) 8.8  (1.38) 3.3  (0.62) 6.6  (1.00)
Upper limbs, Week 16 (n=28,45,38,70) 3.2  (0.70) 6.5  (1.13) 3.5  (0.66) 6.9  (1.28)
Trunk, Baseline (n=31,82,45,133) 1.6  (0.52) 3.2  (0.88) 1.5  (0.53) 2.6  (0.59)
Trunk, Week 4 (n=30,82,43,128) 1.8  (0.53) 5.1  (1.00) 1.6  (0.53) 6.0  (1.05)
Trunk, Week 8 (n=30,70,43,104) 1.9  (0.56) 7.4  (1.73) 1.5  (0.37) 7.9  (1.29)
Trunk, Week 12 (n=28,53,42,84) 1.7  (0.61) 4.4  (0.67) 1.4  (0.39) 5.3  (1.04)
Trunk, Week 16 (n=28,45,38,70) 2.1  (0.74) 4.8  (0.90) 1.8  (0.91) 5.5  (1.05)
Lower limbs, Baseline (n=31,82,45,133) 1.3  (0.37) 3.8  (1.02) 2.1  (0.44) 2.4  (0.49)
Lower limbs, Week 4 (n=30,82,43,128) 1.2  (0.33) 4.9  (0.75) 1.4  (0.38) 5.7  (0.90)
Lower limbs, Week 8 (n=30,70,43,104) 1.5  (0.36) 6.1  (1.07) 1.7  (0.53) 7.5  (1.30)
Lower limbs, Week 12 (n=28,53,42,84) 1.2  (0.35) 7.0  (1.24) 2.4  (0.80) 5.4  (0.95)
Lower limbs, Week 16 (n=28,45,38,70) 1.4  (0.42) 6.0  (1.30) 3.0  (1.03) 5.1  (0.78)
33.Secondary Outcome
Title Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Hide Description Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis.
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
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FAS-C; n equals the number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 75 42 120
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Head/Neck, Baseline (n=27,75,42,120) 4.0  (1.23) 18.6  (2.62) 2.0  (0.61) 18.3  (1.95)
Head/Neck, Week 4 (n=27,74,42,119) 3.6  (1.33) 12.5  (2.09) 2.9  (0.76) 7.5  (1.12)
Head/Neck, Week 8 (n=26,72,41,118) 3.9  (1.25) 9.5  (2.01) 3.3  (1.08) 6.3  (1.02)
Head/Neck, Week 16 (n=23,67,39,101) 4.6  (1.50) 9.8  (1.97) 1.4  (0.46) 6.1  (1.31)
Upper limbs, Baseline (n=27,75,42,120) 3.2  (0.72) 12.5  (1.73) 3.6  (0.63) 13.2  (1.40)
Upper limbs, Week 4 (n=27,74,42,119) 3.4  (0.82) 11.1  (1.92) 4.1  (0.90) 8.4  (1.23)
Upper limbs, Week 8 (n=26,72,41,118) 4.1  (0.99) 8.9  (1.83) 3.7  (0.92) 6.7  (0.97)
Upper limbs, Week 16 (n=23,67,39,101) 4.0  (1.02) 7.0  (1.33) 4.6  (1.24) 5.3  (1.02)
Trunk, Baseline (n=27,75,42,120) 2.2  (0.77) 10.9  (1.73) 2.0  (0.85) 11.1  (1.35)
Trunk, Week 4 (n=27,74,42,119) 2.0  (0.68) 11.1  (2.33) 3.2  (1.72) 6.7  (1.10)
Trunk, Week 8 (n=26,72,41,118) 2.4  (0.73) 10.2  (2.16) 3.5  (1.76) 5.9  (1.15)
Trunk, Week 16 (n=23,67,39,101) 3.0  (0.96) 7.1  (1.54) 4.7  (2.34) 4.8  (1.16)
Lower limbs, Baseline (n=27,75,42,120) 1.4  (0.44) 9.4  (1.21) 3.7  (1.15) 10.4  (1.27)
Lower limbs, Week 4 (n=27,74,42,119) 1.1  (0.27) 9.5  (1.81) 2.6  (0.95) 6.9  (1.06)
Lower limbs, Week 8 (n=26,72,41,118) 1.4  (0.38) 8.0  (1.73) 3.0  (1.10) 5.8  (0.92)
Lower limbs, Week 16 (n=23,67,39,101) 1.8  (0.45) 6.5  (1.26) 3.0  (1.33) 3.5  (0.64)
34.Secondary Outcome
Title Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
Hide Description Baseline defined as the last observation up to first dosing date in Period A.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
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FAS-A; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 326 331
Mean (Standard Error)
Unit of Measure: percent change in psoriatic BSA
Head/Neck, Week 4 (n=326,331) -7.9  (0.71) -11.7  (0.86)
Head/Neck, Week 8 (n=322,323) -13.8  (0.98) -16.0  (1.04)
Head/Neck, Week 16 (n=311,306) -15.4  (1.13) -17.9  (1.07)
Head/Neck, Week 24 (n=277,279) -14.9  (1.21) -18.6  (1.12)
Upper limbs, Week 4 (n=326,331) -4.9  (0.58) -8.8  (0.80)
Upper limbs, Week 8 (n=322,323) -9.7  (0.77) -14.1  (0.92)
Upper limbs, Week 16 (n=311,306) -13.1  (0.89) -17.4  (1.03)
Upper limbs, Week 24 (n=277,279) -14.2  (0.98) -18.5  (1.01)
Trunk, Week 4 (n=326,331) -5.5  (0.67) -8.6  (0.86)
Trunk, Week 8 (n=322,323) -9.9  (0.87) -13.8  (1.03)
Trunk, Week 16 (n=311,306) -12.9  (0.98) -16.9  (1.17)
Trunk, Week 24 (n=277,279) -13.4  (1.12) -17.8  (1.12)
Lower limbs, Week 4 (n=326,331) -4.8  (0.57) -8.6  (0.85)
Lower limbs, Week 8 (n=322,323) -10.4  (0.82) -14.8  (0.99)
Lower limbs, Week 16 (n=311,306) -15.9  (1.04) -20.3  (1.10)
Lower limbs, Week 24 (n=277,279) -17.1  (1.09) -21.2  (1.07)
35.Secondary Outcome
Title Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
Hide Description Baseline defined as the last observation up to first dosing date in Period B.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals the number of participants with observations
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 30 82 43 128
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Head/Neck, Week 4 (n=30,82,43,128) -0.3  (0.98) 8.0  (1.49) 0.7  (0.44) 9.3  (1.53)
Head/Neck, Week 8 (n=30,70,43,104) 0.4  (1.41) 10.0  (1.87) 0.6  (0.50) 12.8  (1.86)
Head/Neck, Week 12 (n=28,53,42,84) -0.9  (1.58) 11.8  (2.71) 1.8  (0.69) 10.4  (1.95)
Head/Neck, Week 16 (n=28,45,38,70) -0.8  (1.42) 7.9  (1.70) 1.2  (0.75) 8.3  (1.66)
Upper limbs, Week 4 (n=30,82,43,128) 0.4  (0.33) 2.3  (1.14) -0.2  (0.29) 4.5  (0.76)
Upper limbs, Week 8 (n=30,70,43,104) 0.8  (0.47) 4.1  (0.99) 0.4  (0.54) 6.2  (0.96)
Upper limbs, Week 12 (n=28,53,42,84) 1.0  (0.51) 4.8  (1.14) 0.4  (0.50) 4.7  (0.86)
Upper limbs, Week 16 (n=28,45,38,70) 1.1  (0.55) 2.7  (0.75) 0.6  (0.46) 4.9  (0.95)
Trunk, Week 4 (n=30,82,43,128) 0.1  (0.50) 1.9  (1.17) 0.0  (0.51) 3.3  (0.74)
Trunk, Week 8 (n=30,70,43,104) 0.3  (0.54) 4.0  (1.34) -0.2  (0.56) 5.6  (0.97)
Trunk, Week 12 (n=28,53,42,84) 0.0  (0.68) 2.9  (0.75) -0.2  (0.63) 3.8  (0.75)
Trunk, Week 16 (n=28,45,38,70) 0.4  (0.73) 3.3  (0.81) 0.0  (1.09) 3.9  (0.71)
Lower limbs, Week 4 (n=30,82,43,128) -0.2  (0.42) 1.1  (0.92) -0.7  (0.39) 3.2  (0.68)
Lower limbs, Week 8 (n=30,70,43,104) 0.2  (0.43) 2.7  (0.83) -0.5  (0.66) 5.3  (0.98)
Lower limbs, Week 12 (n=28,53,42,84) -0.1  (0.47) 4.6  (1.19) 0.3  (0.84) 3.9  (0.84)
Lower limbs, Week 16 (n=28,45,38,70) 0.0  (0.51) 3.3  (0.94) 0.7  (0.86) 3.7  (0.76)
36.Secondary Outcome
Title Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
Hide Description Baseline defined as the last observation up to first dosing date in Period C.
Time Frame Weeks 4, 8, and 16 (Period C)
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Hide Analysis Population Description
FAS-C; n equals the number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 74 42 119
Mean (Standard Error)
Unit of Measure: percent psoriatic BSA
Head/Neck, Week 4 (n=27,74,42,119) -0.3  (0.92) -6.4  (1.40) 0.9  (0.81) -10.8  (1.53)
Head/Neck, Week 8 (n=26,72,41,118) 0.0  (1.07) -8.6  (1.68) 1.2  (0.91) -10.9  (1.51)
Head/Neck, Week 16 (n=23,67,39,101) 0.4  (1.41) -8.1  (2.04) -0.7  (0.77) -11.6  (1.84)
Upper limbs, Week 4 (n=27,74,42,119) 0.1  (0.26) -1.6  (0.90) 0.5  (0.69) -4.9  (0.94)
Upper limbs, Week 8 (n=26,72,41,118) 0.8  (0.50) -3.0  (0.85) 0.1  (0.53) -6.3  (1.11)
Upper limbs, Week 16 (n=23,67,39,101) 0.7  (0.97) -5.0  (1.15) 1.0  (0.99) -7.6  (1.20)
Trunk, Week 4 (n=27,74,42,119) -0.2  (0.20) 0.1  (1.12) 1.3  (1.87) -4.6  (0.88)
Trunk, Week 8 (n=26,72,41,118) 0.1  (0.43) -1.1  (1.04) 1.5  (1.92) -4.8  (0.88)
Trunk, Week 16 (n=23,67,39,101) 0.7  (0.82) -4.1  (1.44) 2.7  (2.46) -5.6  (1.02)
Lower limbs, Week 4 (n=27,74,42,119) -0.3  (0.36) -0.1  (1.44) -1.1  (0.93) -3.6  (0.97)
Lower limbs, Week 8 (n=26,72,41,118) -0.1  (0.52) -1.3  (1.50) -0.7  (0.78) -4.3  (0.85)
Lower limbs, Week 16 (n=23,67,39,101) 0.2  (0.60) -2.3  (1.15) -0.9  (1.14) -6.1  (0.93)
37.Secondary Outcome
Title Mean PASI Score During Initial CP-690,550 Treatment (Period A)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis.
Time Frame Baseline and Weeks 4, 8, 16, and 24 (Period A)
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FAS-A
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline (n=331,335) 21.1  (0.5) 20.9  (0.4)
Week 4 (n=326,331) 13.5  (0.5) 10.4  (0.4)
Week 8 (n=322,323) 10.1  (0.4) 6.5  (0.4)
Week 16 (n=311,307) 8.1  (0.4) 5.0  (0.4)
Week 24 (n=277,279) 7.6  (0.4) 4.4  (0.4)
38.Secondary Outcome
Title Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Time Frame Baseline and Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals the number of participants with observations
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline (n=31,82,45,133) 1.6  (0.2) 1.8  (0.2) 1.7  (0.2) 1.5  (0.1)
Week 4 (n=30,82,43,128) 2.0  (0.3) 5.0  (0.6) 1.8  (0.3) 5.3  (0.6)
Week 8 (n=30,70,43,104) 2.4  (0.4) 6.5  (0.7) 2.0  (0.4) 6.8  (0.7)
Week 12 (n=28,53,42,84) 2.3  (0.4) 6.4  (0.7) 2.5  (0.4) 5.6  (0.6)
Week 16 (n=28,45,38,70) 2.7  (0.5) 5.5  (0.7) 2.9  (0.5) 5.5  (0.6)
39.Secondary Outcome
Title Mean PASI Score During the CP-690,550 Re-Treatment (Period C)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C; n equals the number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 75 42 120
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline (n=27,75,42,120) 2.7  (0.5) 9.9  (0.9) 3.4  (0.6) 9.8  (0.8)
Week 4 (n=27,74,42,119) 2.5  (0.4) 7.8  (1.0) 3.3  (0.6) 5.0  (0.5)
Week 8 (n=26,72,41,118) 2.6  (0.5) 6.0  (0.9) 3.2  (0.6) 4.1  (0.5)
Week 16 (n=23,67,39,101) 2.9  (0.5) 5.2  (0.8) 3.5  (0.7) 3.5  (0.5)
40.Secondary Outcome
Title Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 326 331
Mean (Standard Error)
Unit of Measure: scores on a scale
Week 4 (n=326,331) -7.6  (0.4) -10.5  (0.4)
Week 8 (n=322,323) -11.1  (0.4) -14.2  (0.5)
Week 16 (n=311,307) -13.1  (0.5) -15.8  (0.5)
Week 24 (n=277,279) -13.4  (0.5) -16.0  (0.5)
41.Secondary Outcome
Title Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals the number of participants with observations
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for 5 mg CP-690,550 BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 BID (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 30 82 43 128
Mean (Standard Error)
Unit of Measure: scores on a scale
Week 4 (n=30,82,43,128) 0.4  (0.2) 3.3  (0.6) 0.2  (0.2) 3.8  (0.5)
Week 8 (n=30,70,43,104) 0.9  (0.4) 4.9  (0.7) 0.3  (0.3) 5.4  (0.6)
Week 12 (n=28,53,42,84) 0.7  (0.4) 4.8  (0.7) 0.9  (0.4) 4.5  (0.6)
Week 16 (n=28,45,38,70) 1.0  (0.5) 4.1  (0.6) 1.4  (0.4) 4.4  (0.5)
42.Secondary Outcome
Title Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C.
Time Frame Weeks 4, 8, and 16 (Period C)
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Hide Analysis Population Description
FAS-C; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 74 42 119
Mean (Standard Error)
Unit of Measure: scores on a scale
Week 4 (n=27,74,42,119) -0.2  (0.4) -2.3  (0.7) -0.1  (0.5) -4.8  (0.6)
Week 8 (n=26,72,41,118) 0.0  (0.5) -3.8  (0.7) -0.2  (0.4) -5.4  (0.6)
Week 16 (n=23,67,39,101) 0.1  (0.6) -4.5  (0.9) -0.0  (0.7) -5.9  (0.6)
43.Secondary Outcome
Title Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Time Frame Baseline and Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Mean (Standard Error)
Unit of Measure: score on a scale
Erythema Head/Neck, Baseline (n=331,335) 2.2  (0.1) 2.2  (0.1)
Erythema Head/Neck, Week 4 (n=326,331) 1.4  (0.1) 1.1  (0.1)
Erythema Head/Neck, Week 8 (n=322,323) 1.1  (0.1) 0.7  (0.0)
Erythema Head/Neck, Week 16 (n=311,307) 1.0  (0.1) 0.7  (0.1)
Erythema Head/Neck, Week 24 (n=277,279) 1.0  (0.1) 0.6  (0.1)
Induration Head/Neck, Baseline (n=331,335) 2.0  (0.1) 1.9  (0.1)
Induration Head/Neck, Week 4 (n=326,331) 1.2  (0.1) 0.9  (0.1)
Induration Head/Neck, Week 8 (n=322,323) 0.9  (0.1) 0.6  (0.0)
Induration Head/Neck, Week 16 (n=311,307) 0.8  (0.1) 0.5  (0.0)
Induration Head/Neck, Week 24 (n=277,279) 0.8  (0.1) 0.5  (0.0)
Scaling Head/Neck, Baseline (n=331,335) 2.2  (0.1) 2.1  (0.1)
Scaling Head/Neck, Week 4 (n=326,331) 1.3  (0.1) 1.0  (0.1)
Scaling Head/Neck, Week 8 (n=322,323) 1.0  (0.1) 0.6  (0.0)
Scaling Head/Neck, Week 16 (n=311,307) 0.9  (0.1) 0.6  (0.1)
Scaling Head/Neck, Week 24 (n=277,279) 0.9  (0.1) 0.6  (0.1)
Erythema Upper limbs, Baseline (n=331,335) 2.8  (0.0) 2.8  (0.0)
Erythema Upper limbs, Week 4 (n=326,331) 1.9  (0.0) 1.6  (0.0)
Erythema Upper limbs, Week 8 (n=322,323) 1.6  (0.1) 1.2  (0.0)
Erythema Upper limbs, Week 16 (n=311,307) 1.4  (0.1) 1.1  (0.1)
Erythema Upper limbs, Week 24 (n=277,279) 1.4  (0.1) 1.0  (0.1)
Induration Upper limbs, Baseline (n=331,335) 2.6  (0.0) 2.6  (0.0)
Induration Upper limbs, Week 4 (n=326,331) 1.9  (0.0) 1.5  (0.1)
Induration Upper limbs, Week 8 (n=322,323) 1.5  (0.1) 1.1  (0.1)
Induration Upper limbs, Week 16 (n=311,307 1.4  (0.1) 1.0  (0.1)
Induration Upper limbs, Week 24 (n=277,279) 1.4  (0.1) 1.0  (0.1)
Scaling Upper limbs, Baseline (n=331,335) 2.7  (0.0) 2.6  (0.0)
Scaling Upper limbs, Week 4 (n=326,331) 1.9  (0.0) 1.5  (0.1)
Scaling Upper limbs, Week 8 (n=322,323) 1.5  (0.1) 1.1  (0.1)
Scaling Upper limbs, Week 16 (n=311,307) 1.4  (0.1) 1.0  (0.1)
Scaling Upper limbs, Week 24 (n=277,279) 1.4  (0.1) 1.0  (0.1)
Erythema Trunk, Baseline (n=331,335) 2.9  (0.0) 2.8  (0.0)
Erythema Trunk, Week 4 (n=326,331) 1.9  (0.1) 1.6  (0.1)
Erythema Trunk, Week 8 (n=322,323) 1.6  (0.1) 1.1  (0.1)
Erythema Trunk, Week 16 (n=311,307) 1.4  (0.1) 0.9  (0.1)
Erythema Trunk, Week 24 (n=277,279) 1.4  (0.1) 0.8  (0.1)
Induration Trunk, Baseline (n=331,335) 2.6  (0.0) 2.6  (0.0)
Induration Trunk, Week 4 (n=326,331) 1.8  (0.1) 1.4  (0.1)
Induration Trunk, Week 8 (n=322,323) 1.4  (0.1) 0.9  (0.1)
Induration Trunk, Week 16 (n=311,307) 1.2  (0.1) 0.8  (0.1)
Induration Trunk, Week 24 (n=277,279) 1.2  (0.1) 0.7  (0.1)
Scaling Trunk, Baseline (n=331,335) 2.6  (0.0) 2.5  (0.0)
Scaling Trunk, Week 4 (n=326,331) 1.7  (0.1) 1.4  (0.1)
Scaling Trunk, Week 8 (n=322,323) 1.3  (0.1) 0.9  (0.1)
Scaling Trunk, Week 16 (n=311,307) 1.2  (0.1) 0.7  (0.1)
Scaling Trunk, Week 24 (n=277,279) 1.1  (0.1) 0.7  (0.1)
Erythema Lower limbs, Baseline (n=331,335) 3.1  (0.0) 3.1  (0.0)
Erythema Lower limbs, Week 4 (n=326,331) 2.2  (0.0) 1.9  (0.1)
Erythema Lower limbs, Week 8 (n=322,323) 1.9  (0.1) 1.4  (0.1)
Erythema Lower limbs, Week 16 (n=311,307) 1.5  (0.1) 1.1  (0.1)
Erythema Lower limbs, Week 24 (n=277,279) 1.4  (0.1) 1.0  (0.1)
Induration Lower limbs, Baseline (n=331,335) 2.9  (0.0) 2.9  (0.0)
Induration Lower limbs, Week 4 (n=326,331) 2.1  (0.0) 1.6  (0.1)
Induration Lwer limbs, Week 8 (n=322,323) 1.6  (0.1) 1.2  (0.1)
Induration Lower limbs, Week 16 (n=311,307) 1.3  (0.1) 0.9  (0.1)
Induration Lower limbs, Week 24 (n=277,279) 1.3  (0.1) 0.9  (0.1)
Scaling Lower limbs, Baseline (n=331,335) 2.9  (0.0) 2.9  (0.0)
Scaling Lower limbs, Week 4 (n=326,331) 2.0  (0.1) 1.8  (0.1)
Scaling Lower limbs, Week 8 (n=322,323) 1.6  (0.1) 1.2  (0.1)
Scaling Lower limbs, Week 16 (n=311,307) 1.3  (0.1) 1.0  (0.1)
Scaling Lower limbs, Week 24 (n=277,279) 1.3  (0.1) 1.0  (0.1)
44.Secondary Outcome
Title Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Time Frame Baseline and Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for CP-690,550 5 mg BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 31 82 45 133
Mean (Standard Error)
Unit of Measure: score on a scale
Erythema Head/Neck, Baseline (n=31,82,45,133) 0.5  (0.1) 0.4  (0.1) 0.3  (0.1) 0.3  (0.0)
Erythema Head/Neck, Week 4 (n=30,82,43,128) 0.6  (0.1) 1.1  (0.1) 0.4  (0.1) 1.1  (0.1)
Erythema Head/Neck, Week 8 (n=30,70,43,104) 0.7  (0.2) 1.2  (0.1) 0.3  (0.1) 1.3  (0.1)
Erythema Head/Neck, Week 12 (n=28,53,42,84) 0.7  (0.2) 1.1  (0.2) 0.5  (0.1) 1.1  (0.1)
Erythema Head/Neck, Week 16 (n=28,45,38,70) 0.7  (0.2) 0.8  (0.1) 0.5  (0.1) 1.0  (0.1)
Induration Head/Neck, Baseline (n=31,82,45,133) 0.3  (0.1) 0.4  (0.1) 0.1  (0.1) 0.2  (0.0)
Induration Head/Neck, Week 4 (n=30,82,43,128) 0.4  (0.1) 0.9  (0.1) 0.3  (0.1) 0.9  (0.1)
Induration Head/Neck, Week 8 (n=30,70,43,104) 0.4  (0.1) 1.0  (0.1) 0.3  (0.1) 1.1  (0.1)
Induration Head/Neck, Week 12 (n=28,53,42,84) 0.4  (0.1) 0.9  (0.1) 0.4  (0.1) 0.9  (0.1)
Induration Head/Neck, Week 16 (n=28,45,38,70) 0.5  (0.1) 0.7  (0.1) 0.3  (0.1) 0.8  (0.1)
Scaling Head/Neck, Baseline (n=31,82,45,133) 0.4  (0.1) 0.4  (0.1) 0.2  (0.1) 0.3  (0.1)
Scaling Head/Neck, Week 4 (n=30,82,43,128) 0.4  (0.1) 1.0  (0.1) 0.3  (0.1) 1.1  (0.1)
Scaling Head/Neck, Week 8 (n=30,70,43,104) 0.5  (0.1) 1.1  (0.1) 0.4  (0.1) 1.3  (0.1)
Scaling Head/Neck, Week 12 (n=28,53,42,84) 0.6  (0.1) 1.1  (0.1) 0.5  (0.1) 1.1  (0.1)
Scaling Head/Neck, Week 16 (n=28,45,38,70) 0.6  (0.2) 0.8  (0.1) 0.5  (0.1) 0.9  (0.1)
Erythema Upper limbs, Baseline (n=31,82,45,133) 0.6  (0.1) 0.6  (0.1) 0.8  (0.1) 0.5  (0.1)
Erythema Upper limbs, Week 4 (n=30,82,43,128) 0.8  (0.1) 1.3  (0.1) 0.8  (0.1) 1.3  (0.1)
Erythema Upper limbs, Week 8 (n=30,70,43,104) 0.9  (0.2) 1.5  (0.1) 0.9  (0.1) 1.4  (0.1)
Erythema Upper limbs, Week 12 (n=28,53,42,84) 1.0  (0.2) 1.5  (0.1) 0.9  (0.1) 1.3  (0.1)
Erythema Upper limbs, Week 16 (n=28,45,38,70) 1.0  (0.2) 1.4  (0.1) 1.1  (0.1) 1.3  (0.1)
Induration Upper limbs, Baseline (n=31,82,45,133) 0.7  (0.1) 0.6  (0.1) 0.6  (0.1) 0.5  (0.1)
Induration Upper limbs, Week 4 (n=30,82,43,128) 0.8  (0.1) 1.3  (0.1) 0.7  (0.1) 1.1  (0.1)
Induration Upper limbs, Week 8 (n=30,70,43,104) 0.8  (0.2) 1.5  (0.1) 0.8  (0.1) 1.4  (0.1)
Induration Upper limbs, Week 12 (n=28,53,42,84) 1.0  (0.2) 1.5  (0.1) 1.0  (0.1) 1.3  (0.1)
Induration Upper limbs, Week 16 (n=28,45,38,70) 1.1  (0.2) 1.3  (0.2) 1.1  (0.1) 1.4  (0.1)
Scaling Upper limbs, Baseline (n=31,82,45,133) 0.8  (0.2) 0.6  (0.1) 0.7  (0.1) 0.5  (0.1)
Scaling Upper limbs, Week 4 (n=30,82,43,128) 0.8  (0.2) 1.3  (0.1) 0.7  (0.1) 1.2  (0.1)
Scaling Upper limbs, Week 8 (n=30,70,43,104) 0.9  (0.2) 1.4  (0.1) 0.8  (0.1) 1.4  (0.1)
Scaling Upper limbs, Week 12 (n=28,53,42,84) 1.0  (0.2) 1.4  (0.1) 1.0  (0.1) 1.4  (0.1)
Scaling Upper limbs, Week 16 (n=28,45,38,70) 1.1  (0.2) 1.3  (0.2) 1.3  (0.2) 1.4  (0.1)
Erythema Trunk, Baseline (n=31,82,45,133) 0.5  (0.1) 0.4  (0.1) 0.4  (0.1) 0.4  (0.1)
Erythema Trunk, Week 4 (n=30,82,43,128) 0.7  (0.2) 1.1  (0.1) 0.4  (0.1) 1.1  (0.1)
Erythema Trunk, Week 8 (n=30,70,43,104) 0.9  (0.2) 1.5  (0.1) 0.5  (0.1) 1.4  (0.1)
Erythema Trunk, Week 12 (n=28,53,42,84) 0.7  (0.2) 1.5  (0.2) 0.5  (0.1) 1.1  (0.1)
Erythema Trunk, Week 16 (n=28,45,38,70) 0.9  (0.2) 1.3  (0.2) 0.5  (0.1) 1.1  (0.1)
Induration Trunk, Baseline (n=31,82,45,133) 0.4  (0.1) 0.3  (0.1) 0.3  (0.1) 0.3  (0.0)
Induration Trunk, Week 4 (n=30,82,43,128) 0.4  (0.1) 0.9  (0.1) 0.3  (0.1) 0.8  (0.1)
Induration Trunk, Week 8 (n=30,70,43,104) 0.5  (0.1) 1.2  (0.1) 0.4  (0.1) 1.1  (0.1)
Induration Trunk, Week 12 (n=28,53,42,84) 0.5  (0.2) 1.2  (0.1) 0.5  (0.1) 0.9  (0.1)
Induration Trunk, Week 16 (n=28,45,38,70) 0.6  (0.2) 1.2  (0.2) 0.6  (0.1) 1.1  (0.1)
Scaling Trunk, Baseline (n=31,82,45,133) 0.3  (0.1) 0.3  (0.1) 0.3  (0.1) 0.3  (0.0)
Scaling Trunk, Week 4 (n=30,82,43,128) 0.4  (0.1) 0.9  (0.1) 0.3  (0.1) 0.8  (0.1)
Scaling Trunk, Week 8 (n=30,70,43,104) 0.5  (0.1) 1.2  (0.1) 0.4  (0.1) 1.1  (0.1)
Scaling Trunk, Week 12 (n=28,53,42,84) 0.4  (0.1) 1.2  (0.1) 0.5  (0.1) 0.9  (0.1)
Scaling Trunk, Week 16 (n=28,45,38,70) 0.6  (0.2) 1.1  (0.2) 0.6  (0.1) 1.0  (0.1)
Erythema Lower limbs, Baseline (n=31,82,45,133) 0.5  (0.1) 0.6  (0.1) 0.8  (0.1) 0.5  (0.1)
Erythema Lower limbs, Week 4 (n=30,82,43,128) 0.6  (0.1) 1.3  (0.1) 0.8  (0.1) 1.3  (0.1)
Erythema Lower limbs, Week 8 (n=30,70,43,104) 0.8  (0.2) 1.6  (0.1) 0.8  (0.2) 1.5  (0.1)
Erythema Lower limbs, Week 12 (n=28,53,42,84) 0.8  (0.2) 1.6  (0.2) 0.9  (0.2) 1.4  (0.1)
Erythema Lower limbs, Week 16 (n=28,45,38,70) 0.8  (0.2) 1.6  (0.2) 1.0  (0.2) 1.3  (0.1)
Induration Lower limbs, Baseline (n=31,82,45,133) 0.5  (0.1) 0.5  (0.1) 0.6  (0.1) 0.3  (0.0)
Induration Lower limbs, Week 4 (n=30,82,43,128) 0.6  (0.1) 1.0  (0.1) 0.6  (0.1) 1.0  (0.1)
Induration Lower limbs, Week 8 (n=30,70,43,104) 0.6  (0.2) 1.4  (0.1) 0.6  (0.1) 1.3  (0.1)
Induration Lower limbs, Week 12 (n=28,53,42,84) 0.6  (0.2) 1.4  (0.1) 0.8  (0.1) 1.2  (0.1)
Induration Lower limbs, Week 16 (n=28,45,38,70) 0.6  (0.1) 1.4  (0.2) 0.9  (0.2) 1.2  (0.1)
Scaling Lower limbs, Baseline (n=31,82,45,133) 0.5  (0.1) 0.4  (0.1) 0.6  (0.1) 0.4  (0.0)
Scaling Lower limbs, Week 4 (n=30,82,43,128) 0.5  (0.1) 1.0  (0.1) 0.6  (0.1) 1.0  (0.1)
Scaling Lower limbs, Week 8 (n=30,70,43,104) 0.7  (0.2) 1.3  (0.1) 0.6  (0.1) 1.3  (0.1)
Scaling Lower limbs, Week 12 (n=28,53,42,84) 0.6  (0.2) 1.4  (0.1) 0.7  (0.1) 1.3  (0.1)
Scaling Lower limbs, Week 16 (n=28,45,38,70) 0.6  (0.2) 1.4  (0.2) 0.9  (0.2) 1.3  (0.1)
45.Secondary Outcome
Title Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.
Time Frame Baseline and Weeks 4, 8, and 16 (Period C)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-C; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 75 42 120
Mean (Standard Error)
Unit of Measure: score on a scale
Erythema Head/Neck, Baseline (n=27,75,42,120) 0.7  (0.2) 1.5  (0.1) 0.5  (0.1) 1.6  (0.1)
Erythema Head/Neck, Week 4 (n=27,74,42,119) 0.6  (0.1) 1.1  (0.1) 0.6  (0.1) 0.7  (0.1)
Erythema Head/Neck, Week 8 (n=26,72,41,118) 0.8  (0.2) 0.8  (0.1) 0.5  (0.1) 0.7  (0.1)
Erythema Head/Neck, Week 16 (n=23,67,39,101) 0.7  (0.2) 1.0  (0.1) 0.4  (0.1) 0.6  (0.1)
Induration Head/Neck, Baseline (n=27,75,42,120) 0.5  (0.1) 1.3  (0.1) 0.4  (0.1) 1.4  (0.1)
Induration Head/Neck, Week 4 (n=27,74,42,119) 0.3  (0.1) 0.9  (0.1) 0.4  (0.1) 0.6  (0.1)
Induration Head/Neck, Week 8 (n=26,72,41,118) 0.4  (0.2) 0.8  (0.1) 0.3  (0.1) 0.5  (0.1)
Induration Head/Neck, Week 16 (n=23,67,39,101) 0.4  (0.1) 0.7  (0.1) 0.2  (0.1) 0.5  (0.1)
Scaling Head/Neck, Baseline (n=27,75,42,120) 0.6  (0.2) 1.4  (0.1) 0.5  (0.1) 1.6  (0.1)
Scaling Head/Neck, Week 4 (n=27,74,42,119) 0.5  (0.2) 1.0  (0.1) 0.6  (0.1) 0.7  (0.1)
Scaling Head/Neck, Week 8 (n=26,72,41,118) 0.7  (0.2) 0.9  (0.1) 0.5  (0.1) 0.6  (0.1)
Scaling Head/Neck, Week 16 (n=23,67,39,101) 0.5  (0.2) 0.9  (0.1) 0.4  (0.1) 0.5  (0.1)
Erythema Upper limbs, Baseline (n=27,75,42,120) 1.0  (0.2) 1.9  (0.1) 1.2  (0.2) 1.8  (0.1)
Erythema Upper limbs, Week 4 (n=27,74,42,119) 0.9  (0.2) 1.5  (0.1) 1.1  (0.2) 1.1  (0.1)
Erythema Upper limbs, Week 8 (n=26,72,41,118) 0.8  (0.2) 1.2  (0.1) 1.0  (0.1) 1.0  (0.1)
Erythema Upper limbs, Week 16 (n=23,67,39,101) 1.0  (0.2) 1.3  (0.1) 1.1  (0.2) 0.9  (0.1)
Induration Upper limbs, Baseline (n=27,75,42,120) 1.1  (0.2) 1.9  (0.1) 1.1  (0.1) 1.7  (0.1)
Induration Upper limbs, Week 4 (n=27,74,42,119) 1.0  (0.2) 1.4  (0.1) 1.1  (0.1) 1.1  (0.1)
Induration Upper limbs, Week 8 (n=26,72,41,118) 1.0  (0.2) 1.2  (0.1) 1.0  (0.1) 1.0  (0.1)
Induration Upper limbs, Week 16 (n=23,67,39,101) 1.1  (0.2) 1.2  (0.1) 1.1  (0.2) 0.9  (0.1)
Scaling Upper limbs, Baseline (n=27,75,42,120) 1.1  (0.2) 1.8  (0.1) 1.3  (0.2) 1.8  (0.1)
Scaling Upper limbs, Week 4 (n=27,74,42,119) 1.1  (0.2) 1.5  (0.1) 1.1  (0.1) 1.1  (0.1)
Scaling Upper limbs, Week 8 (n=26,72,41,118) 0.9  (0.2) 1.2  (0.1) 1.1  (0.1) 1.0  (0.1)
Scaling Upper limbs, Week 16 (n=23,67,39,101) 1.2  (0.2) 1.3  (0.1) 1.1  (0.2) 0.9  (0.1)
Erythema Trunk, Baseline (n=27,75,42,120) 0.9  (0.2) 1.9  (0.1) 0.7  (0.2) 1.8  (0.1)
Erythema Trunk, Week 4 (n=27,74,42,119) 0.8  (0.2) 1.4  (0.1) 0.6  (0.1) 1.0  (0.1)
Erythema Trunk, Week 8 (n=26,72,41,118) 0.8  (0.2) 1.2  (0.1) 0.7  (0.1) 0.8  (0.1)
Erythema Trunk, Week 16 (n=23,67,39,101) 0.7  (0.2) 1.1  (0.1) 0.6  (0.2) 0.8  (0.1)
Induration Trunk, Baseline (n=27,75,42,120) 0.7  (0.2) 1.7  (0.1) 0.7  (0.2) 1.5  (0.1)
Induration Trunk, Week 4 (n=27,74,42,119) 0.6  (0.2) 1.2  (0.1) 0.6  (0.1) 0.8  (0.1)
Induration Trunk, Week 8 (n=26,72,41,118) 0.5  (0.2) 1.0  (0.1) 0.6  (0.1) 0.7  (0.1)
Induration Trunk, Week 16 (n=23,67,39,101) 0.5  (0.2) 0.9  (0.1) 0.6  (0.1) 0.7  (0.1)
Scaling Trunk, Baseline (n=27,75,42,120) 0.7  (0.2) 1.6  (0.1) 0.7  (0.2) 1.5  (0.1)
Scaling Trunk, Week 4 (n=27,74,42,119) 0.5  (0.1) 1.3  (0.1) 0.6  (0.1) 0.9  (0.1)
Scaling Trunk, Week 8 (n=26,72,41,118) 0.5  (0.1) 1.0  (0.1) 0.6  (0.1) 0.7  (0.1)
Scaling Trunk, Week 16 (n=23,67,39,101) 0.4  (0.1) 0.9  (0.1) 0.6  (0.1) 0.7  (0.1)
Erythema Lower limbs, Baseline (n=27,75,42,120) 0.7  (0.2) 2.1  (0.1) 1.1  (0.2) 1.9  (0.1)
Erythema Lower limbs, Week 4 (n=27,74,42,119) 0.7  (0.2) 1.6  (0.1) 1.0  (0.2) 1.3  (0.1)
Erythema Lower limbs, Week 8 (n=26,72,41,118) 0.8  (0.2) 1.3  (0.1) 0.9  (0.2) 1.0  (0.1)
Erythema Lower limbs, Week 16 (n=23,67,39,101) 1.0  (0.2) 1.3  (0.1) 0.9  (0.2) 0.9  (0.1)
Induration Lower limbs, Baseline (n=27,75,42,120) 0.6  (0.1) 1.9  (0.1) 1.0  (0.2) 1.7  (0.1)
Induration Lower limbs, Week 4 (n=27,74,42,119) 0.7  (0.2) 1.5  (0.1) 0.9  (0.2) 1.0  (0.1)
Induration Lower limbs, Week 8 (n=26,72,41,118) 0.7  (0.2) 1.3  (0.1) 0.9  (0.2) 0.9  (0.1)
Induration Lower limbs, Week 16 (n=23,67,39,101) 0.9  (0.2) 1.1  (0.1) 0.9  (0.2) 0.8  (0.1)
Scaling Lower limbs, Baseline (n=27,75,42,120) 0.6  (0.2) 1.8  (0.1) 1.0  (0.2) 1.8  (0.1)
Scaling Lower limbs, Week 4 (n=27,74,42,119) 0.7  (0.2) 1.5  (0.1) 0.9  (0.2) 1.1  (0.1)
Scaling Lower limbs, Week 8 (n=26,72,41,118) 0.7  (0.2) 1.2  (0.1) 0.8  (0.2) 1.0  (0.1)
Scaling Lower limbs, Week 16 (n=23,67,39,101) 1.0  (0.2) 1.1  (0.1) 0.8  (0.2) 0.8  (0.1)
46.Secondary Outcome
Title Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-A; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
Overall Number of Participants Analyzed 326 331
Mean (Standard Error)
Unit of Measure: score on a scale
Erythema Head/Neck, Week 4 (n=326,331) -0.8  (0.1) -1.2  (0.1)
Erythema Head/Neck, Week 8 (n=322,323) -1.1  (0.1) -1.5  (0.1)
Erythema Head/Neck, Week 16 (n=311,307) -1.2  (0.1) -1.6  (0.1)
Erythema Head/Neck, Week 24 (n=277,279) -1.2  (0.1) -1.6  (0.1)
Induration Head/Neck, Week 4 (n=326,331) -0.8  (0.0) -1.1  (0.1)
Induration Head/Neck, Week 8 (n=322,323) -1.1  (0.1) -1.4  (0.1)
Induration Head/Neck, Week 16 (n=311,307) -1.2  (0.1) -1.4  (0.1)
Induration Head/Neck, Week 24 (n=277,279) -1.1  (0.1) -1.4  (0.1)
Scaling Head/Neck, Week 4 (n=326,331) -0.9  (0.1) -1.1  (0.1)
Scaling Head/Neck, Week 8 (n=322,323) -1.2  (0.1) -1.5  (0.1)
Scaling Head/Neck, Week 16 (n=311,307) -1.3  (0.1) -1.5  (0.1)
Scaling Head/Neck, Week 24 (n=277,279) -1.2  (0.1) -1.5  (0.1)
Erythema Upper limbs, Week 4 (n=326,331) -0.9  (0.0) -1.2  (0.0)
Erythema Upper limbs, Week 8 (n=322,323) -1.3  (0.1) -1.5  (0.1)
Erythema Upper limbs, Week 16 (n=311,307) -1.4  (0.1) -1.7  (0.1)
Erythema Upper limbs, Week 24 (n=277,279) -1.5  (0.1) -1.8  (0.1)
Induration Upper limbs, Week 4 (n=326,331) -0.8  (0.0) -1.2  (0.1)
Induration Upper limbs, Week 8 (n=322,323) -1.1  (0.1) -1.5  (0.1)
Induration Upper limbs, Week 16 (n=311,307 -1.2  (0.1) -1.6  (0.1)
Induration Upper limbs, Week 24 (n=277,279) -1.2  (0.1) -1.6  (0.1)
Scaling Upper limbs, Week 4 (n=326,331) -0.7  (0.0) -1.1  (0.1)
Scaling Upper limbs, Week 8 (n=322,323) -1.1  (0.1) -1.5  (0.1)
Scaling Upper limbs, Week 16 (n=311,307) -1.2  (0.1) -1.6  (0.1)
Scaling Upper limbs, Week 24 (n=277,279) -1.3  (0.1) -1.6  (0.1)
Erythema Trunk, Week 4 (n=326,331) -0.9  (0.0) -1.3  (0.1)
Erythema Trunk, Week 8 (n=322,323) -1.3  (0.1) -1.7  (0.1)
Erythema Trunk, Week 16 (n=311,307) -1.5  (0.1) -1.9  (0.1)
Erythema Trunk, Week 24 (n=277,279) -1.5  (0.1) -2.0  (0.1)
Induration Trunk, Week 4 (n=326,331) -0.8  (0.0) -1.2  (0.1)
Induration Trunk, Week 8 (n=322,323) -1.2  (0.1) -1.7  (0.1)
Induration Trunk, Week 16 (n=311,307) -1.4  (0.1) -1.8  (0.1)
Induration Trunk, Week 24 (n=277,279) -1.4  (0.1) -1.9  (0.1)
Scaling Trunk, Week 4 (n=326,331) -0.8  (0.1) -1.1  (0.1)
Scaling Trunk, Week 8 (n=322,323) -1.2  (0.1) -1.6  (0.1)
Scaling Trunk, Week 16 (n=311,307) -1.4  (0.1) -1.8  (0.1)
Scaling Trunk, Week 24 (n=277,279) -1.4  (0.1) -1.8  (0.1)
Erythema Lower limbs, Week 4 (n=326,331) -0.9  (0.0) -1.2  (0.0)
Erythema Lower limbs, Week 8 (n=322,323) -1.3  (0.1) -1.7  (0.1)
Erythema Lower limbs, Week 16 (n=311,307) -1.6  (0.1) -2.0  (0.1)
Erythema Lower limbs, Week 24 (n=277,279) -1.7  (0.1) -2.1  (0.1)
Induration Lower limbs, Week 4 (n=326,331) -0.8  (0.0) -1.3  (0.1)
Induration Lower limbs, Week 8 (n=322,323) -1.2  (0.1) -1.7  (0.1)
Induration Lower limbs, Week 16 (n=311,307) -1.5  (0.1) -2.0  (0.1)
Induration Lower limbs, Week 24 (n=277,279) -1.6  (0.1) -2.0  (0.1)
Scaling Lower limbs, Week 4 (n=326,331) -0.9  (0.0) -1.2  (0.1)
Scaling Lower limbs, Week 8 (n=322,323) -1.3  (0.1) -1.8  (0.1)
Scaling Lower limbs, Week 16 (n=311,307) -1.6  (0.1) -2.0  (0.1)
Scaling Lower limbs, Week 24 (n=277,279) -1.6  (0.1) -2.0  (0.1)
47.Secondary Outcome
Title Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B.
Time Frame Weeks 4, 8, 12, and 16 (Period B)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-B; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID (Period B) Placebo for CP-690,550 5 mg BID (Period B) CP-690,550 10 mg BID (Period B) Placebo for 10 mg CP-690,550 (Period B)
Hide Arm/Group Description:
Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
Overall Number of Participants Analyzed 30 82 45 128
Mean (Standard Error)
Unit of Measure: score on a scale
Erythema Head/Neck, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.8  (0.1) 0.2  (0.1) 0.8  (0.1)
Erythema Head/Neck, Week 8 (n=30,70,43,104) 0.2  (0.2) 0.9  (0.1) 0.1  (0.1) 1.1  (0.1)
Erythema Head/Neck, Week 12 (n=28,53,42,84) 0.2  (0.1) 0.8  (0.1) 0.2  (0.1) 0.9  (0.1)
Erythema Head/Neck, Week 16 (n=28,45,38,70) 0.1  (0.1) 0.6  (0.1) 0.2  (0.1) 0.8  (0.1)
Induration Head/Neck, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.5  (0.1) 0.1  (0.1) 0.7  (0.1)
Induration Head/Neck, Week 8 (n=30,70,43,104) 0.1  (0.1) 0.7  (0.1) 0.2  (0.1) 0.9  (0.1)
Induration Head/Neck, Week 12 (n=28,53,42,84) 0.1  (0.1) 0.6  (0.1) 0.3  (0.1) 0.8  (0.1)
Induration Head/Neck, Week 16 (n=28,45,38,70) 0.1  (0.1) 0.5  (0.1) 0.2  (0.1) 0.7  (0.1)
Scaling Head/Neck, Week 4 (n=30,82,43,128) 0.0  (0.1) 0.6  (0.1) 0.2  (0.1) 0.8  (0.1)
Scaling Head/Neck, Week 8 (n=30,70,43,104) 0.1  (0.1) 0.8  (0.1) 0.2  (0.1) 1.0  (0.1)
Scaling Head/Neck, Week 12 (n=28,53,42,84) 0.1  (0.1) 0.7  (0.1) 0.3  (0.1) 1.0  (0.1)
Scaling Head/Neck, Week 16 (n=28,45,38,70) 0.1  (0.1) 0.7  (0.1) 0.3  (0.1) 0.8  (0.1)
Erythema Upper limbs, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.7  (0.1) 0.1  (0.1) 0.7  (0.1)
Erythema Upper limbs, Week 8 (n=30,70,43,104) 0.3  (0.1) 0.9  (0.1) 0.2  (0.1) 0.9  (0.1)
Erythema Upper limbs, Week 12 (n=28,53,42,84) 0.4  (0.2) 0.9  (0.1) 0.2  (0.1) 0.9  (0.1)
Erythema Upper limbs, Week 16 (n=28,45,38,70) 0.4  (0.1) 0.8  (0.1) 0.4  (0.1) 0.9  (0.1)
Induration Upper limbs, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.6  (0.1) 0.1  (0.1) 0.6  (0.1)
Induration Upper limbs, Week 8 (n=30,70,43,104) 0.2  (0.1) 0.9  (0.1) 0.2  (0.1) 0.9  (0.1)
Induration Upper limbs, Week 12 (n=28,53,42,84) 0.4  (0.2) 0.9  (0.1) 0.4  (0.1) 0.9  (0.1)
Induration Upper limbs, Week 16 (n=28,45,38,70) 0.4  (0.2) 0.9  (0.1) 0.5  (0.1) 0.9  (0.1)
Scaling Upper limbs, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.7  (0.1) 0.1  (0.1) 0.7  (0.1)
Scaling Upper limbs, Week 8 (n=30,70,43,104) 0.1  (0.1) 0.9  (0.1) 0.1  (0.1) 0.9  (0.1)
Scaling Upper limbs, Week 12 (n=28,53,42,84) 0.3  (0.1) 0.9  (0.1) 0.3  (0.1) 1.0  (0.1)
Scaling Upper limbs, Week 16 (n=28,45,38,70) 0.3  (0.2) 0.9  (0.1) 0.6  (0.1) 1.1  (0.1)
Erythema Trunk, Week 4 (n=30,82,43,128) 0.2  (0.1) 0.7  (0.1) 0.0  (0.1) 0.7  (0.1)
Erythema Trunk, Week 8 (n=30,70,43,104) 0.4  (0.1) 1.0  (0.1) 0.1  (0.1) 1.0  (0.1)
Erythema Trunk, Week 12 (n=28,53,42,84) 0.1  (0.1) 1.2  (0.2) 0.2  (0.1) 0.8  (0.1)
Erythema Trunk, Week 16 (n=28,45,38,70) 0.3  (0.2) 1.0  (0.2) 0.2  (0.1) 0.8  (0.1)
Induration Trunk, Week 4 (n=30,82,43,128) -0.0  (0.1) 0.6  (0.1) 0.0  (0.1) 0.5  (0.1)
Induration Trunk, Week 8 (n=30,70,43,104) 0.1  (0.1) 0.9  (0.1) 0.2  (0.1) 0.8  (0.1)
Induration Trunk, Week 12 (n=28,53,42,84) 0.1  (0.1) 1.0  (0.1) 0.3  (0.1) 0.7  (0.1)
Induration Trunk, Week 16 (n=28,45,38,70) 0.2  (0.1) 1.0  (0.2) 0.3  (0.1) 0.8  (0.1)
Scaling Trunk, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.6  (0.1) -0.0  (0.1) 0.5  (0.1)
Scaling Trunk, Week 8 (n=30,70,43,104) 0.2  (0.1) 0.9  (0.1) 0.2  (0.1) 0.9  (0.1)
Scaling Trunk, Week 12 (n=28,53,42,84) 0.1  (0.1) 0.9  (0.1) 0.2  (0.1) 0.6  (0.1)
Scaling Trunk, Week 16 (n=28,45,38,70) 0.4  (0.2) 0.9  (0.2) 0.3  (0.2) 0.8  (0.1)
Erythema Lower limbs, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.7  (0.1) 0.0  (0.1) 0.8  (0.1)
Erythema Lower limbs, Week 8 (n=30,70,43,104) 0.3  (0.2) 1.0  (0.1) -0.0  (0.1) 1.1  (0.1)
Erythema Lower limbs, Week 12 (n=28,53,42,84) 0.3  (0.2) 1.0  (0.1) 0.1  (0.2) 1.0  (0.1)
Erythema Lower limbs, Week 16 (n=28,45,38,70) 0.3  (0.2) 1.1  (0.2) 0.3  (0.2) 0.9  (0.1)
Induration Lower limbs, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.5  (0.1) 0.0  (0.1) 0.7  (0.1)
Induration Lower limbs, Week 8 (n=30,70,43,104) 0.1  (0.2) 0.9  (0.1) 0.0  (0.1) 1.0  (0.1)
Induration Lower limbs, Week 12 (n=28,53,42,84) 0.1  (0.2) 0.9  (0.1) 0.2  (0.1) 0.9  (0.1)
Induration Lower limbs, Week 16 (n=28,45,38,70) 0.1  (0.1) 0.9  (0.1) 0.4  (0.2) 0.9  (0.1)
Scaling Lower limbs, Week 4 (n=30,82,43,128) 0.1  (0.1) 0.6  (0.1) -0.0  (0.1) 0.6  (0.1)
Scaling Lower limbs, Week 8 (n=30,70,43,104) 0.3  (0.2) 0.9  (0.1) -0.0  (0.1) 0.9  (0.1)
Scaling Lower limbs, Week 12 (n=28,53,42,84) 0.2  (0.2) 0.9  (0.1) 0.0  (0.1) 0.9  (0.1)
Scaling Lower limbs, Week 16 (n=28,45,38,70) 0.2  (0.2) 1.0  (0.1) 0.3  (0.2) 1.0  (0.1)
48.Secondary Outcome
Title Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Hide Description Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90–100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C.
Time Frame Weeks 4, 8, and 16 (Period C)
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Hide Analysis Population Description
FAS-C; n equals number of participants with an observation
Arm/Group Title CP-690,550 5 mg BID / CP-690,550 5 mg BID Placebo BID / CP-690,550 5 mg BID CP-690,550 10 mg BID / CP-690,550 10 mg BID Placebo BID / CP-690,550 10 mg BID
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Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
Overall Number of Participants Analyzed 27 74 42 119
Mean (Standard Error)
Unit of Measure: score on a scale
Erythema Head/Neck, Week 4 (n=27,74,42,119) -0.1  (0.1) -0.4  (0.1) 0.1  (0.1) -0.9  (0.1)
Erythema Head/Neck, Week 8 (n=26,72,41,118) 0.1  (0.1) -0.7  (0.1) -0.0  (0.1) -0.9  (0.1)
Erythema Head/Neck, Week 16 (n=23,67,39,101) -0.1  (0.1) -0.4  (0.1) -0.1  (0.1) -0.9  (0.1)
Induration Head/Neck, Week 4 (n=27,74,42,119) -0.2  (0.1) -0.4  (0.1) 0.0  (0.1) -0.8  (0.1)
Induration Head/Neck, Week 8 (n=26,72,41,118) -0.0  (0.2) -0.5  (0.1) -0.0  (0.1) -0.8  (0.1)
Induration Head/Neck, Week 16 (n=23,67,39,101) -0.1  (0.1) -0.6  (0.1) -0.2  (0.1) -0.9  (0.1)
Scaling Head/Neck, Week 4 (n=27,74,42,119) -0.1  (0.1) -0.4  (0.1) 0.0  (0.1) -0.9  (0.1)
Scaling Head/Neck, Week 8 (n=26,72,41,118) 0.1  (0.1) -0.5  (0.1) -0.0  (0.1) -0.9  (0.1)
Scaling Head/Neck, Week 16 (n=23,67,39,101) -0.1  (0.1) -0.5  (0.1) -0.2  (0.1) -1.0  (0.1)
Erythema Upper limbs, Week 4 (n=27,74,42,119) -0.0  (0.1) -0.4  (0.1) -0.0  (0.1) -0.6  (0.1)
Erythema Upper limbs, Week 8 (n=26,72,41,118) -0.1  (0.1) -0.7  (0.1) -0.1  (0.1) -0.8  (0.1)
Erythema Upper limbs, Week 16 (n=23,67,39,101) 0.0  (0.2) -0.6  (0.1) -0.2  (0.2) -0.8  (0.1)
Induration Upper limbs, Week 4 (n=27,74,42,119) -0.0  (0.1) -0.5  (0.1) -0.0  (0.1) -0.6  (0.1)
Induration Upper limbs, Week 8 (n=26,72,41,118) -0.0  (0.1) -0.7  (0.1) -0.1  (0.1) -0.8  (0.1)
Induration Upper limbs, Week 16 (n=23,67,39,101) -0.0  (0.2) -0.6  (0.1) -0.1  (0.2) -0.8  (0.1)
Scaling Upper limbs, Week 4 (n=27,74,42,119) 0.0  (0.1) -0.3  (0.1) -0.2  (0.1) -0.7  (0.1)
Scaling Upper limbs, Week 8 (n=26,72,41,118) -0.0  (0.2) -0.6  (0.1) -0.1  (0.1) -0.8  (0.1)
Scaling Upper limbs, Week 16 (n=23,67,39,101) 0.0  (0.2) -0.5  (0.1) -0.2  (0.2) -0.8  (0.1)
Erythema Trunk, Week 4 (n=27,74,42,119) -0.1  (0.1) -0.5  (0.1) -0.1  (0.1) -0.8  (0.1)
Erythema Trunk, Week 8 (n=26,72,41,118) -0.1  (02) -0.7  (01) 0.0  (0.2) -1.0  (0.1)
Erythema Trunk, Week 16 (n=23,67,39,101) -0.2  (0.2) -0.8  (0.1) -0.1  (0.2) -1.0  (0.1)
Induration Trunk, Week 4 (n=27,74,42,119) -0.1  (0.1) -0.5  (0.1) -0.1  (0.1) -0.7  (0.1)
Induration Trunk, Week 8 (n=26,72,41,118) -0.1  (0.1) -0.7  (0.1) -0.2  (0.1) -0.8  (0.1)
Induration Trunk, Week 16 (n=23,67,39,101) -0.2  (0.2) -0.8  (0.1) -0.2  (0.2) -0.8  (0.1)
Scaling Trunk, Week 4 (n=27,74,42,119) -0.2  (0.2) -0.4  (0.1) -0.1  (0.1) -0.6  (0.1)
Scaling Trunk, Week 8 (n=26,72,41,118) 0.0  (0.1) -0.6  (0.1) -0.1  (0.1) -0.8  (0.1)
Scaling Trunk, Week 16 (n=23,67,39,101) -0.3  (0.2) -0.7  (0.1) -0.1  (0.1) -0.8  (0.1)
Erythema Lower limbs, Week 4 (n=27,74,42,119) 0.0  (0.1) -0.5  (0.1) -0.1  (0.1) -0.7  (0.1)
Erythema Lower limbs, Week 8 (n=26,72,41,118) 0.1  (0.1) -0.7  (0.1) -0.2  (0.1) -0.9  (0.1)
Erythema Lower limbs, Week 16 (n=23,67,39,101) 0.2  (0.2) -0.7  (0.1) -0.2  (0.2) -1.0  (0.1)
Induration Lower limbs, Week 4 (n=27,74,42,119) 0.2  (0.1) -0.4  (0.1) -0.1  (0.1) -0.7  (0.1)
Induration Lower limbs, Week 8 (n=26,72,41,118) 0.1  (0.2) -0.6  (0.1) -0.1  (0.1) -0.8  (0.1)
Induration Lower limbs, Week 16 (n=23,67,39,101) 0.3  (0.2) -0.7  (0.1) -0.1  (0.2) -0.9  (0.1)
Scaling Lower limbs, Week 4 (n=27,74,42,119) 0.1  (0.1) -0.3  (0.1) -0.1  (0.1) -0.7  (0.1)
Scaling Lower limbs, Week 8 (n=26,72,41,118) 0.1  (0.2) -0.6  (0.1) -0.1  (0.1) -0.8  (0.1)
Scaling Lower limbs, Week 16 (n=23,67,39,101) 0.3  (0.2) -0.6  (0.1) -0.2  (0.2) -0.9  (0.1)
49.Secondary Outcome
Title Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A
Hide Description PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
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Hide Analysis Population Description
FAS-A; NRI
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
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Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
28.70
(23.83 to 33.57)
54.63
(49.30 to 59.96)
Week 8
55.29
(49.93 to 60.64)
75.52
(70.92 to 80.13)
Week 16
65.26
(60.13 to 70.39)
79.40
(75.07 to 83.73)
Week 24
59.52
(54.23 to 64.80)
73.13
(68.39 to 77.88)
50.Secondary Outcome
Title Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A
Hide Description PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
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Hide Analysis Population Description
FAS-A
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
1.21
(0.03 to 2.39)
6.27
(3.67 to 8.86)
Week 8
8.76
(5.72 to 11.81)
24.78
(20.15 to 29.40)
Week 16
18.73
(14.53 to 22.93)
36.72
(31.55 to 41.88)
Week 24
20.24
(15.91 to 24.57)
37.31
(32.13 to 42.49)
51.Secondary Outcome
Title Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A
Hide Description PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Time Frame Weeks 4, 8, 16, and 24 (Period A)
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Hide Analysis Population Description
FAS-A
Arm/Group Title CP-690,550 5 mg BID (Period A) CP-690,550 10 mg BID (Period A)
Hide Arm/Group Description:
Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
Overall Number of Participants Analyzed 331 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 4
0.91
(0.0 to 1.93)
2.09
(0.56 to 3.62)
Week 8
2.72
(0.97 to 4.47)
7.46
(4.65 to 10.28)
Week 16
7.25
(4.46 to 10.04)
15.82
(11.91 to 19.73)
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